An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
CheckMate 274
A Phase 3 Randomized, Double-blind, Multi-center Study of Adjuvant Nivolumab Versus Placebo in Subjects With High Risk Invasive Urothelial Carcinoma (CheckMate 274: CHECKpoint Pathway and nivoluMAb Clinical Trial Evaluation 274)
2 other identifiers
interventional
709
29 countries
184
Brief Summary
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2016
Longer than P75 for phase_3
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedStudy Start
First participant enrolled
March 22, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2020
CompletedResults Posted
Study results publicly available
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 27, 2027
ExpectedOctober 16, 2025
October 1, 2025
4.3 years
December 14, 2015
July 16, 2021
October 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Disease Free Survival (DFS)
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
approximately up to 48 months
Disease Free Survival (DFS) in PD-L1 Expression ≥ 1% Population
The time between the date of randomization and the date of first documented recurrence (local urothelial tract, local non-urothelial tract or distant), or death due to any cause, whichever occurs first.
approximately up to 48 months
Secondary Outcomes (6)
Non-Urothelial Tract Recurrence Free Survival
up to 53 months
Non-Urothelial Tract Recurrence Free Survival in PD-L1 Expression ≥ 1% Population
up to 53 months
Overall Survival
on going
Overall Survival in Participants With PD-L1 Expression ≥ 1%
on going
Disease Specific Survival
on going
- +1 more secondary outcomes
Study Arms (2)
Nivolumab
EXPERIMENTALNivolumab dose as specified
Placebo
PLACEBO COMPARATORPlacebo dose as specified
Interventions
Eligibility Criteria
You may qualify if:
- Must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis
- Must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days
- Must have disease free status as determined by imaging within 4 weeks of dosing
- Tumor tissue must be provided for biomarker analysis
- Patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy
You may not qualify if:
- Partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy)
- Secondary Treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer
- Subjects with active, known or suspected autoimmune disease
- Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
- Condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration
- Positive test for hepatitis B virus surface antigen (HBV s Ag) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Ono Pharmaceutical Co. Ltdcollaborator
Study Sites (188)
Alaska Urological Institute dba Alaska Clinical Research Center
Anchorage, Alaska, 99503, United States
Local Institution - 0179
Tucson, Arizona, 85704, United States
Local Institution - 0061
Clovis, California, 93611, United States
Local Institution - 0172
Sacramento, California, 95817, United States
Local Institution - 0005
San Francisco, California, 94115, United States
Local Institution - 0178
Lakewood, Colorado, 80228, United States
Local Institution - 0167
Gainesville, Florida, 32610, United States
Local Institution - 0030
Miami Beach, Florida, 33140, United States
Local Institution - 0008
Tampa, Florida, 33612, United States
Local Institution - 0168
Maywood, Illinois, 60153, United States
Local Institution - 0094
Fort Wayne, Indiana, 46804, United States
Local Institution - 0171
New Orleans, Louisiana, 70112, United States
Local Institution - 0173
Grand Rapids, Michigan, 49503, United States
Local Institution - 0051
Burnsville, Minnesota, 55337, United States
Local Institution - 0004
Rochester, Minnesota, 55905, United States
Local Institution - 0003
Omaha, Nebraska, 68130, United States
Local Institution - 0177
Las Vegas, Nevada, 89148, United States
Local Institution - 0176
Albany, New York, 12208, United States
Local Institution - 0157
Buffalo, New York, 14263, United States
Local Institution - 0007
Mineola, New York, 11501, United States
Local Institution - 0001
New York, New York, 10021, United States
Local Institution - 0006
New York, New York, 10029, United States
Local Institution - 0166
Chapel Hill, North Carolina, 27599-7305, United States
Local Institution
Durham, North Carolina, 27708, United States
Local Institution - 0044
Portland, Oregon, 97213, United States
Local Institution - 0010
Portland, Oregon, 97239, United States
Local Institution - 0180
Tigard, Oregon, 97223, United States
Local Institution - 0074
Allentown, Pennsylvania, 18103, United States
Local Institution - 0011
Pittsburgh, Pennsylvania, 15212, United States
Local Institution - 0040
Pittsburgh, Pennsylvania, 15232, United States
Local Institution - 0169
Myrtle Beach, South Carolina, 29572, United States
Local Institution - 0009
Chattanooga, Tennessee, 37404, United States
Local Institution - 0234
Norfolk, Virginia, 23502, United States
Local Institution - 0021
Berazategui, Buenos Aires, 1880, Argentina
Local Institution - 0090
Capital Federal, Buenos Aires, 1426, Argentina
Local Institution - 0089
Ciudad Autonoma de Buenos Aire, Buenos Aires, 1181, Argentina
Local Institution - 0022
Ciudad AutĂ³noma de BuenosAires, Buenos Aires, C1280AEB, Argentina
Local Institution - 0020
San Miguel de TucumĂ¡n, TucumĂ¡n Province, 4000, Argentina
Local Institution - 0102
Viedma, 8500, Argentina
Local Institution - 0048
Liverpool, New South Wales, 2170, Australia
Local Institution - 0047
St Leonards, New South Wales, 2065, Australia
Local Institution - 0046
Waratah, New South Wales, 2298, Australia
Local Institution - 0050
Elizabeth Vale, South Australia, 5112, Australia
Local Institution - 0184
Frankston, Victoria, 3199, Australia
Local Institution - 0175
Perth, Western Australia, 6150, Australia
Local Institution - 0133
Linz, 4010, Austria
Local Institution - 0136
Salzburg, 5020, Austria
Local Institution - 0132
Vienna, 1090, Austria
Local Institution - 0183
Vienna, 1090, Austria
Local Institution - 0029
Hasselt, 3500, Belgium
Local Institution - 0027
Liège, 4000, Belgium
Local Institution - 0071
IjuĂ, Rio Grande do Sul, 98700-000, Brazil
Local Institution - 0072
Porto Alegre, Rio Grande do Sul, 90610000, Brazil
Local Institution - 0070
Barretos, SĂ£o Paulo, 14780-070, Brazil
Local Institution - 0073
Cerqueira CĂ©sar, SĂ£o Paulo, 01246-000, Brazil
Local Institution - 0231
Rio de Janeiro, 20231-050, Brazil
Local Institution - 0100
SĂ£o Paulo, 04014-002, Brazil
Local Institution - 0139
Edmonton, Alberta, T6G 1Z2, Canada
Local Institution - 0101
Montreal, Quebec, H2X 0A9, Canada
Local Institution - 0109
Montreal, Quebec, H4A 3J1, Canada
Local Institution - 0112
Sherbrooke, Quebec, J1H 5N4, Canada
Local Institution - 0038
Viña del Mar, RegiĂ³n de ValparaĂso, 2540364, Chile
Local Institution - 0099
Santiago, Santiago Metropolitan, Chile
Local Institution - 0137
Temuco, 4810297, Chile
Local Institution - 0191
Beijing, Beijing Municipality, 100001, China
Local Institution - 0206
Beijing, Beijing Municipality, 100034, China
Local Institution - 0192
Beijing, Beijing Municipality, 100050, China
Local Institution - 0210
Chongqing, Chongqing Municipality, 400030, China
Local Institution - 0198
Fuzhou, Fujian, 350001, China
Local Institution - 0222
Guangzhou, Guangdong, 510230, China
Local Institution - 0203
Guangzhou, Guangdong, 510288, China
Local Institution - 0227
Nanning, Guangxi, 530021, China
Local Institution - 0196
Wuhan, Hubei, 430030, China
Local Institution - 0220
Nanjing, Jiangsu, 210008, China
Local Institution - 0204
Nanjing, Jiangsu, 210029, China
Local Institution - 0223
Nanchang, Jiangxi, 330006, China
Local Institution
Xi'an, Shan3xi, 710061, China
Local Institution - 0212
Yantai, Shandong, 264000, China
Local Institution - 0193
Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0202
Shanghai, Shanghai Municipality, 200032, China
Local Institution - 0199
Shanghai, Shanghai Municipality, 200040, China
Local Institution - 0217
Shanghai, Shanghai Municipality, 200040, China
Local Institution - 0229
Chengdu, Sichuan, 610041, China
Local Institution - 0219
Chengdu, Sichuan, 610072, China
Local Institution - 0221
Hangzhou, Zhejiang, 310009, China
Local Institution - 0195
Hangzhou, Zhejiang, 310014, China
Local Institution - 0230
Wenzhou, Zhejiang, 32500, China
Local Institution - 0092
BogotĂ¡, 0, Colombia
Local Institution - 0093
Floridablanca, 681004, Colombia
Local Institution - 0091
MedellĂn, 050034, Colombia
Local Institution - 0108
Aalborg, 9100, Denmark
Local Institution - 0106
Aarhus N, 8200, Denmark
Local Institution - 0107
Copenhagen, 2100, Denmark
Local Institution - 0233
Clermont-Ferrand, 63000, France
Local Institution - 0115
La Roche-sur-Yon, 85000, France
Local Institution - 0080
Marseille, 13273, France
Local Institution - 0081
Paris, 75475, France
Local Institution - 0113
Strasbourg, 67200, France
Local Institution - 0097
Suresnes, 92151, France
Local Institution - 0098
Villejuif, 94800, France
Local Institution - 0131
Chemnitz, 09130, Germany
Local Institution - 0125
Essen, 45136, Germany
Local Institution - 0127
Greifswald, 17475, Germany
Local Institution - 0126
Hamburg, 20246, Germany
Local Institution - 0124
Heidelberg, 69126, Germany
Local Institution - 0123
Jena, 07747, Germany
Local Institution - 0188
Marburg, 35043, Germany
Local Institution - 0122
Munich, 81675, Germany
Local Institution - 0128
MĂ¼nster, 48149, Germany
Local Institution - 0185
Nuremberg, 90419, Germany
Local Institution - 0130
Regensburg, 93053, Germany
Local Institution - 0129
Stuttgart, 70174, Germany
Local Institution - 0110
Athens, 115 28, Greece
Local Institution - 0111
Thessaloniki, 54007, Greece
Local Institution - 0054
Wilton, CORK, 0, Ireland
Local Institution - 0052
Dublin, Ireland
Local Institution - 0118
Haifa, 3109601, Israel
Local Institution - 0121
Jerusalem, 91120, Israel
Local Institution - 0120
Ramat Gan, 5262100, Israel
Local Institution - 0119
Ẕerifin, 70300, Israel
Local Institution - 0088
Arezzo, 52100, Italy
Local Institution - 0197
Bergamo, 24127, Italy
Local Institution - 0082
Milan, 20133, Italy
Local Institution - 0084
Pisa, 56126, Italy
Local Institution - 0189
Reggio Emilia, 42100, Italy
Local Institution - 0085
Roma, 00144, Italy
Local Institution - 0086
Roma, 00152, Italy
Local Institution - 0083
Siena, 53100, Italy
Local Institution - 0142
Akita, Akita, 0108543, Japan
Local Institution - 0144
Hirosaki, Aomori, 0368563, Japan
Local Institution - 0162
Fukuoka, Fukuoka, 8128582, Japan
Local Institution - 0160
Sapporo, Hokkaido, 060-8543, Japan
Local Institution - 0161
Sapporo, Hokkaido, 0608648, Japan
Local Institution - 0148
Tsukuba, Ibaraki, 3058576, Japan
Local Institution - 0163
Nagasaki, Nagasaki, 8528501, Japan
Local Institution - 0150
Niigata, Niigata, 9518520, Japan
Local Institution - 0141
Okayama, Okayama-ken, 700-8558, Japan
Local Institution - 0149
Sayama, Osaka, 589-8511, Japan
Local Institution - 0151
Hamamatasu, Shizuoka, 431-3192, Japan
Local Institution - 0146
Bunkyo-ku, Tokyo, 1138603, Japan
Local Institution - 0145
Shinjuku-Ku, Tokyo, 1608582, Japan
Local Institution - 0147
Shinjuku-ku, Tokyo, 1628666, Japan
Local Institution - 0143
Chiba, 260-8717, Japan
Local Institution - 0164
Osaka, 5418567, Japan
Local Institution - 0035
Guadalajara, Jalisco, 44270, Mexico
Local Institution - 0138
Df, Mexico City, 06720, Mexico
Local Institution - 0034
Mexico City, Mexico City, 14080, Mexico
Local Institution - 0032
Monterrey, Nuevo LeĂ³n, 64460, Mexico
Local Institution - 0116
MĂ©xico, 06700, Mexico
Local Institution - 0039
MĂ©xico, 14080, Mexico
Local Institution - 0069
Amsterdam, North Holland, 1081 HV, Netherlands
Local Institution - 0068
Maastrict, 6229 HX, Netherlands
Local Institution - 0041
Nijmegen, 6500 HB, Netherlands
Local Institution - 0043
Lima, Lima 41, Peru
Local Institution - 0055
Gdansk, 80-214, Poland
Local Institution - 0057
Lodz, 93-513, Poland
Local Institution - 0187
Warsaw, 02-797, Poland
Local Institution - 0058
Wroclaw, 50-556, Poland
Local Institution - 0186
Wroclaw, 53-413, Poland
Local Institution - 0182
Bucharest, 021389, Romania
Local Institution - 0096
Craiova, 200347, Romania
Local Institution - 0078
FloreÅŸti, 407280, Romania
Local Institution - 0181
Timisoara, Timis, 300239, Romania
Local Institution - 0140
Moscow, 125284, Russia
Local Institution - 0031
Saint Petersburg, 197758, Russia
Local Institution - 0155
Seongnam-si, 13620, South Korea
Local Institution - 0154
Seoul, 03722, South Korea
Local Institution - 0152
Seoul, 05505, South Korea
Local Institution - 0156
Seoul, 06351, South Korea
Local Institution - 0067
Badalona-barcelona, 08916, Spain
Local Institution - 0066
Barcelona, 08035, Spain
Local Institution - 0064
Madrid, 28007, Spain
Local Institution - 0062
Madrid, 28034, Spain
Local Institution - 0063
Madrid, 28041, Spain
Local Institution - 0232
Santander, 39008, Spain
Local Institution - 0065
Seville, 41013, Spain
Local Institution - 0105
Lund, 221 85, Sweden
Local Institution - 0134
Basel, 4031, Switzerland
Local Institution - 0135
Zurich, 8038, Switzerland
Local Institution - 0158
Kaohsiung City, 807, Taiwan
Local Institution - 0159
Taichung, 404, Taiwan
Local Institution - 0153
Taipei, 100, Taiwan
Local Institution - 0025
Manchester, Greater Manchester, M20 4BX, United Kingdom
Local Institution - 0076
Edinburgh, Midlothian, EH4 2XU, United Kingdom
Local Institution - 0024
Sutton, Surrey, SM2 5PT, United Kingdom
Local Institution - 0059
Sheffield, Yorkshire, S10 2SJ, United Kingdom
Local Institution - 0036
London, SE1 9RT, United Kingdom
Local Institution - 0114
London, SW3 6JJ, United Kingdom
Related Publications (6)
Galsky MD, Bajorin DF, Tomita Y, Ye D, Agerbaek M, Enting D, Peer A, Milowsky M, Kobayashi K, Grimm MO, Stenner F, David JM, Li J, Chasalow SD, Nasroulah F, Apfel A, Unsal-Kacmaz K, Necchi A. Adjuvant nivolumab in muscle-invasive urothelial carcinoma: exploratory biomarker analysis of the randomized phase 3 CheckMate 274 trial. Nat Med. 2025 Sep;31(9):3062-3073. doi: 10.1038/s41591-025-03802-8. Epub 2025 Aug 7.
PMID: 40775055DERIVEDGeynisman DM, Chepynoga K, Yates G, Tate A, Kurt M, Patel MY, Teitsson S, Mitra S, Mamtani R. Estimating the Impact of Adjuvant Treatment With Nivolumab on Long-Term Survivorship Rates Compared With Surveillance in Muscle Invasive Urothelial Carcinoma: Mixture Cure Modeling Analyses of Disease-Free Survival From the Phase 3 CheckMate 274 Trial. Clin Genitourin Cancer. 2025 Jun;23(3):102335. doi: 10.1016/j.clgc.2025.102335. Epub 2025 Mar 17.
PMID: 40204616DERIVEDGalsky MD, Witjes JA, Gschwend JE, Milowsky MI, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Agerbaek M, Jha G, Stenner F, Ye D, Giudici F, Dutta S, Askelson M, Nasroulah F, Zhang J, Brophy L, Bajorin DF. Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274. J Clin Oncol. 2025 Jan;43(1):15-21. doi: 10.1200/JCO.24.00340. Epub 2024 Oct 11.
PMID: 39393026DERIVEDBajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Antonio JN Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Treatment of muscle-invasive urothelial cancer with nivolumab (CheckMate 274 study): a plain language summary. Future Oncol. 2023 Feb;19(6):413-426. doi: 10.2217/fon-2022-1294. Epub 2023 Mar 15.
PMID: 36919916DERIVEDWitjes JA, Galsky MD, Gschwend JE, Broughton E, Braverman J, Nasroulah F, Maira-Arce M, Ye X, Shi L, Guo S, Hamilton M, Bajorin DF. Health-related Quality of Life with Adjuvant Nivolumab After Radical Resection for High-risk Muscle-invasive Urothelial Carcinoma: Results from the Phase 3 CheckMate 274 Trial. Eur Urol Oncol. 2022 Oct;5(5):553-563. doi: 10.1016/j.euo.2022.02.003. Epub 2022 Mar 11.
PMID: 35288066DERIVEDBajorin DF, Witjes JA, Gschwend JE, Schenker M, Valderrama BP, Tomita Y, Bamias A, Lebret T, Shariat SF, Park SH, Ye D, Agerbaek M, Enting D, McDermott R, Gajate P, Peer A, Milowsky MI, Nosov A, Neif Antonio J Jr, Tupikowski K, Toms L, Fischer BS, Qureshi A, Collette S, Unsal-Kacmaz K, Broughton E, Zardavas D, Koon HB, Galsky MD. Adjuvant Nivolumab versus Placebo in Muscle-Invasive Urothelial Carcinoma. N Engl J Med. 2021 Jun 3;384(22):2102-2114. doi: 10.1056/NEJMoa2034442.
PMID: 34077643DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 14, 2015
First Posted
December 16, 2015
Study Start
March 22, 2016
Primary Completion
July 17, 2020
Study Completion (Estimated)
May 27, 2027
Last Updated
October 16, 2025
Results First Posted
December 1, 2021
Record last verified: 2025-10